FDA UDI
In Commercial Distribution
🇺🇸 United States
OPRA Implant System
DI: 07340152100566
·
Model: 1357
·
Integrum AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OPRA Implant System
- Primary DI
- 07340152100566
- Version / Model
- 1357
- Catalog Number
- 1357
- Company Name
- Integrum AB
- Labeler DUNS
- 356739813
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-17
- Public Version
- 4
- Public Version Date
- 2020-03-05
- Public Version Status
- Update
- Public Device Record Key
- bc129f53-2ddd-4fef-9675-129cae21dfeb
Device Description
Healing Screw B5
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PJY | Transfemoral Percutaneous Prosthetic | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58743 | Internal-external leg prosthesis osseointegration bar | A rod with a screw-like or press-fit design intended to be implanted into the residual bone of a lower limb (e.g., femur, tibia) after amputation to function as an anchoring fixture and stabilizing bar for the connection of an internal-external leg prosthesis. It is designed to project beyond the bone but not through the skin so that a protruding trans-stomal connector/abutment can be attached to its distal end to interface with the external prosthesis. It is typically composed of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and has a porous surface intended to improve fixation by promoting bone ingrowth (osseointegration). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07340152100566 | GS1 |
Customer Contacts
- Phone
- +46317601060
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H080004 | 000 |